Stability Specialist
The businesses of Merck KGaA, Darmstadt, Germany•St. Louis, MO
About The Position
MilliporeSigma is seeking a highly motivated and detail-oriented Stability Specialist to join our team. The Stability Specialist will be responsible for developing, executing and analyzing stability studies for IVD (In Vitro Diagnostic products). This role will ensure compliance to regulatory guidelines, such as ISO13485 and IVDR. Responsibilities include:
Requirements
- Bachelor's Degree in Biology, Chemistry, Biochemistry or other Life Science discipline
- 2+ years of laboratory or Quality experience
- Good communication, interpersonal, and collaboration skills
- Ability to work effectively in a cross-functional team environment
- Detail-oriented, organized, and able to manage multiple projects simultaneously
- Problem-solving and analytical skills
Nice To Haves
- Previous experience with IHC testing
- Previous experience writing stability protocols and reports
Responsibilities
- Develop and implement stability protocols according to guidelines and internal SOPs
- Execute testing for stability samples, ensuring accuracy and precision
- Monitor and maintain stability chambers and associated equipment
- Document all data accurately in electronic systems
- Analyze stability data and generate reports
- Interpret stability data to assess product shelf life and storage conditions
- Identify and investigate stability trends and deviations
- Prepare stability reports for regulatory submissions and internal documentation
- Ensure stability studies are conducted in compliance with regulatory guidelines, such as IVDR, ISO 13485
Benefits
- health insurance
- paid time off (PTO)
- retirement contributions
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
